Whether the express preemption provision of the Medical Device Amendments to the Food, Drug, and Cosmetic Act, 21 U.S.C. §360k(a), preempts state-law claims seeking damages for injuries caused by medical devices that received premarket approval from the Food and Drug Administration.The lawsuit, Riegel v. Medtronic, was brought by the Donna Riegel, whose husband, Charles, was injured in 1996 when a Medtronic Evergreen balloon angioplasty catheter burst after being over-inflated and left Mr. Riegel injured and disabled. He later died of brain cancer:
(CNNMoney.com) The Riegels sued Medtronic in 2002, but lost in a New York federal district court and then on appeal. The two courts, siding with Medtronic, ruled that a 1976 amendment to the federal Food, Drug and Cosmetic Act protects medical device makers from being sued.This case has important implications that extend beyond just the device industry. With the FDA now being asked to regulate everything from food products, over-the-counter advertising, drugs, and medical devices, a ruling in Medtronic's favor might become a large legal defense barrier for all sorts of manufacturers.
"The defendant says you can't sue us in state or federal court because it's pre-empted by the federal amendment from 1976," said Wayne P. Smith, a lawyer for Riegel. "It's a very devastating defense."
Medtronic spokesman Robert Clark said his company will ask the Supreme Court to uphold the appeals court decision ruling against Riegel. Clark said that doctor malpractice, not device malfunction, caused the catheter to rupture because it was inflated beyond its FDA-approved limits.
"The product did not malfunction," said Clark. "The physician used the product in a manner that was outside its label and its intention. In this case, it was expanded beyond the labeled indication."